Dual Antiplatele duration according the Bleeding Risk
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0005356
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 3600
? Patients who have agreed to participate in the study among
adults aged 19 or older who are in the high-risk group of bleeding(HBR) after
the treatment of a coronary artery disease(CAD) with percutaneous coronary
intervetion(PCI) are targeted. The criteria for the HBR are as follows. 1)
Definitions of HBR: Patients are considered to be at HBR if at least 1 major or
2 minor criteria are met. ? Major criteria: Anticipated use of long-term oral
anticoagulation Severe or end-stage chronic kidney disease(CKD) (eGFR <30
mL/min) Hemoglobin(Hb) <11 g/dL Spontaneous bleeding requiring
hospitalization or transfusion in the past 6 months or at any time, if recurrent
Moderate or severe baseline thrombocytopenia (platelet count <100×109/L)
Chronic bleeding diathesis Liver cirrhosis with portal hypertension Active
malignancy (defined as diagnosis within 12 months and/or ongoing requirement for
treatment, excluding nonmelanoma skin cancer) within the past 12 months Previous
spontaneous intracranial hemorrhage(ICH) (at any time) or Previous traumatic ICH
within the past 12 months or Presence of a brain arteriovenous
malformation(bAVM) or Moderate or severe ischemic stroke (defined National
Institutes of Health Stroke Scale score =5) within the past 6 months
Nondeferrable major surgery on DAPT Recent major surgery or major trauma within
30 days before PCI ? Minor criteria: Age =75 years Moderate CKD (eGFR 30–59
mL/min) Hb 11–12.9 g/dL for men and 11–11.9 g/dL for women Spontaneous bleeding
requiring hospitalization or transfusion within the past 12 months not meeting
the major criterion Long-term use of oral nonsteroidal anti-inflammatory
drugs(NSAIDs) or steroids Any ischemic stroke at any time not meeting the major
criterion ? Those who meet the low bleeding risk(LBR) criteria below among CAD
patients who have undergone a PCI with a Resolute Onyx stent and who have agreed
to participate in clinical research. 2) The criteria of LBR are defined as those
that do not correspond to the major criteria of HBR above, and those that
satisfy the minor criteria are not more than one.
1. Patients subject to DES treatment who belong to a
high-risk group of ischemic clinical events, who meet the following conditions:
A. STEMI(ST-segmentation elevation myocardial infarction) B. Patients with
hemodynamic instability due to a combination of cardiogenic shock or severe
acute heart failure. C. Myocardial infarction and stent thrombosis (or past
history, when this was strongly suspected) that occurred during the use of
anti-platelet drug. D. If the lesion subject to treatment is not 'de novo
lesion' (i.e., treatment for In-stent restenosis lesions) 2. Pregnant woman
3. Patients with allergic reactions to the following drugs or prohibited drug
use: aspirin, clopidogrel, prasugrel, ticaglor, heparin, cult chromium,
sirolimus
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method All-cause death, Any MI, Any revascularization and ISTH Major <br>bleeding events
- Secondary Outcome Measures
Name Time Method target lesion failure [TLF] + definite or probable stent <br>thrombosis, ISTH major bleeding